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The EMEA has approved the marketing authorisation for the HIV drug Atripla (efavirenz, emtricitabine, tenofovir disoproxil fumarate).
The move by the Committee for Medicinal Products for Human Use could signal a revolution in treatment for people suffering from HIV, as they will only have to take a single pill each day.
Atripla can now go on sale in the 27 countries of the EU, as well as Norway and Iceland.
Patients must not have experienced virological failure on any prior antiretroviral therapy, and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Atripla.
The medication was approved by the FDA in July 2006, and has since become the most-prescribed drug for HIV in the USA.
Dr Brian Gazzard, clinical research director at Chelsea and Westminster Hospital in London, commented: “Historically, HIV treatment regimens have been a challenge for many patients since they often combine multiple medications with complex dosing schedule.
“Atripla combines three clinically proven and well-established anti-HIV medicines in a single once-daily pill, and represents an important step forward in dosing simplification.”
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